Agility Symmetric Total Knee System— 510(k) K242412

Name: FDA 510(k) clearance K242412
Creator: U.S. Food and Drug Administration
Published: 2024-11-06

Substantially Equivalent

Medisurge, LLC

FDA 510(k) clearance K242412 for Agility Symmetric Total Knee System, Substantially Equivalent on 2024-11-06. Applicant: Medisurge, LLC. Device class: 2.

Clearance details

Applicant: Medisurge, LLC
Product code: Code MBH
Device class: Class 2
Regulation: 21 CFR 888.3565
Advisory panel: Orthopedic
Date received: 2024-08-14
Decision date: 2024-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBH

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K261275 — Unity Total Knee System, Unity Knee Cementless CR Femur2026-09-17
K261462 — LANDMARK Total Knee System2026-09-08
K253728 — EVOLUTION® AM BIOFOAM® Tibial System2026-08-21
K251840 — Zimmer® Persona® Personalized Knee System2026-05-28
K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)2026-03-09

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.